Severe, Symptomatic Aortic Stenosis
Conditions
Keywords
Aortic Stenosis, Transfemoral, Transcatheter Heart Valve
Brief summary
The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
Detailed description
This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial \[NCT01314313\].
Interventions
Operable subjects
Sponsors
Pacific Clinical Research Group
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 70 years * STS Score \> 4 * Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate
Exclusion criteria
* Age \<70 years * Evidence of an acute myocardial infarction ≤ 30 days * Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified * Stroke or transient ischemic attack (TIA) within 6 months of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VARC-2 Composite Safety Endpoint | 30 days | The primary endpoint is a VARC-2 Composite. It comprises of 1. All cause mortality 2. All stroke 3. Life-threatening bleeding 4. Acute kidney injury - Stage 3 (including renal replacement therapy) 5. Coronary artery obstruction requiring intervention 6. Major vascular complications 7. Valve related dysfunction (requiring repeat procedure) A composite endpoint is an endpoint that is a combination of multiple components. |
Secondary
| Measure | Time frame |
|---|---|
| All Cause Mortality | 30 days |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAVR With SAPIEN XT THV SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects | 199 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
| Overall Study | Exit with other reason | 1 |
| Overall Study | Missed Visit | 1 |
Baseline characteristics
| Characteristic | TAVR With SAPIEN XT THV |
|---|---|
| Age, Continuous | 85.5 Years STANDARD_DEVIATION 4.51 |
| NYHA I/II | 43 Participants |
| NYHA III/IV | 156 Participants |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 91 Participants |
| STS Score | 5.9 units on a scale STANDARD_DEVIATION 2.59 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 199 |
| other Total, other adverse events | 182 / 199 |
| serious Total, serious adverse events | 73 / 199 |
Outcome results
Primary
VARC-2 Composite Safety Endpoint
The primary endpoint is a VARC-2 Composite. It comprises of 1. All cause mortality 2. All stroke 3. Life-threatening bleeding 4. Acute kidney injury - Stage 3 (including renal replacement therapy) 5. Coronary artery obstruction requiring intervention 6. Major vascular complications 7. Valve related dysfunction (requiring repeat procedure) A composite endpoint is an endpoint that is a combination of multiple components.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAVR With SAPIEN XT THV | VARC-2 Composite Safety Endpoint | 12.1 percentage of patients |
Secondary
All Cause Mortality
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAVR With SAPIEN XT THV | All Cause Mortality | 2.5 percentage of patients |
Secondary
All Cause Mortality
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAVR With SAPIEN XT THV | All Cause Mortality | 8.5 percentage of participants |